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Abstract:

The invention relates to a tamperproof seal for a container or a syringe,
with a lockable conical adapter which is sealed in a sterile manner by
means of a rubber stopper and is protected by a safety sleeve, wherein
the safety sleeve, which is pushed non-releasably onto the conical
adapter lock, comprises a retaining part, a break-off part and a
break-off zone located between said parts. The break-off part encloses
the rubber stopper without radical contact. It has a retaining pin, the
free end of which rests axially on the rubber stopper--when the
tamperproof seal is fitted, and it has at least two open apertures. The
length of the break-off part corresponds to at least twice the length of
the internal thread of the conical adapter lock.
The present invention produces a tamperproof seal which ensures safe
handling of the combination comprising the container or syringe and
tamperproof seal.

Claims:

1. Tamperproof seal for a container or a syringe, with a lockable conical
adapter which is sealed in a sterile manner by means of a rubber stopper
(40) and is protected by a safety cap (60), wherein the safety cap (60),
which is pushed non-releasably onto the conical adapter lock, comprises a
retaining part (61), a break-off part (81) and a break-off zone, (97)
located between said parts (61) and (81),characterizedin that the
break-off part (81) surrounds the rubber stopper (40) without radial
contact,in that the break-off part (81) has a retaining pin (93), the
free end of which rests axially on the rubber stopper (40)--when the
tamperproof seal is fitted,in that the break-off part (81) has at least
two open apertures (85, 92), andin that the length of the break-off part
(81) corresponds to at least twice the length of the internal thread (24)
of the conical adapter lock.

2. Tamperproof seal according to claim 1, characterized in that the
lockable conical adapter comprises an outer cone (12) and an internal
thread adapter (20) which can be fitted behind the outer cone (12).

3. Tamperproof seal according to claims 1 and 2, characterized in that the
retaining pin (93) has a diameter which is smaller than the inside
diameter of the discharge bore (13) of the outer cone (12).

4. Tamperproof seal according to claim 1, characterized in that the
retaining pin (93) is of a length which corresponds to at least 0.4 times
the length of the break-off part (81).

5. Tamperproof seal according to claim 3, characterized in that the
retaining pin (93) is in the shape of a truncated cone and is flanked by
two mutually opposite supporting webs (95).

6. Tamperproof seal according to claim 1, characterized in that the rear
region of the interior (89) of the break-off part (81), in which the
retaining pin (93) is located, takes up at least 40% of the entire
interior volume of the break-off part (81).

7. Tamperproof seal according to claim 1, characterized in that the
break-off part (81) has in each case at least one aperture (85, 92) in
its radial outer wall (83) and on its base (91), with the sum of the
cross sections of all of the apertures (85, 92) corresponding to at least
ten times the bore cross section of the discharge bore (13).

8. Tamperproof seal according to claim 1, characterized in that the outer
wall (63) of the retaining part (61) has a structure (64) at least in
some regions.

9. Tamperproof seal according to claim 1, characterized in that the
apertures (85) of the radial outer wall (13) extend in the longitudinal
direction and are of a length which corresponds to at least 60% of the
length of the break-off part (81).

10. Tamperproof seal according to claim 1, characterized in that the
internal thread adapter (20) is arranged in a form-fitting manner at the
rear end of the outer cone (12) in the longitudinal direction of the
conical adapter.

11. Tamperproof seal according to claim 1, characterized in that there is
an encircling annular channel (17) for the form-fitting fastening of the
internal thread adapter (20) to the rear end of the outer cone (12).

12. Tamperproof seal according to claim 1, characterized in that four
break-off webs (98) are arranged in the break-off zone (97) between the
retaining part (61) and the break-off part (81).

13. Tamperproof seal according to claim 12, characterized in that each
break-off web (98) is of the shape of an inclined truncated pyramid, with
the base surface of the truncated pyramid lying on the break-off part
(81).

14. Tamperproof seal according to claim 12, characterized in that the
break-off webs (98) on the retaining part (61) tear off if the bending
torque acting on the break-off part (81) is greater than 25.+-.10 Ncm.

Description:

[0001]The invention relates to a tamperproof seal for a container or a
syringe, with a lockable conical adapter which is sealed in a sterile
manner by means of a rubber stopper and is protected by a safety sleeve,
wherein the safety sleeve, which is pushed non-releasably onto the
conical adapter lock, comprises a retaining part, a break-off part and a
break-off zone located between said parts.

[0002]U.S. Pat. No. 6,520, 935 B1 discloses a tamperproof seal of this
type. In the subject matter therein, the rubber stopper sits in the
break-off part in a form-fitting manner. As a result, the filled
container bearing the tamperproof seal is completely opened upon the
break-off part being broken off or torn off.

[0003]EP 1 034 810 B1 likewise discloses a tamperproof seal with a safety
sleeve which can be partially removed by being broken off. In this case
too, the rubber stopper is pulled from the conical adapter when the
break-off part is broken off.

[0004]The present invention is based on the problem of producing a
tamperproof seal for a container or a syringe, which tamperproof seal
ensures safe handling of the combination comprising the container or
syringe and tamperproof seal and which can be partially removed in a
simple manner such that the container or the syringe is still sealed in a
sterile manner thereafter.

[0005]The problem is solved by the features of Claim 1. To this end, the
break-off part of the safety cap surrounds the rubber stopper without
radial contact. The break-off part has a retaining pin, the free end of
which rests axially on the rubber stopper--when the tamperproof seal is
fitted. The break-off part has at least two open apertures. The length of
the break-off part corresponds to at least twice the length of the
internal thread of the conical adapter lock.

[0006]The present tamperproof seal is used for filled containers or
syringes. In the present case, it guarantees, for example, safe and
sterile sealing of a cartridge filled with a diagnostic means for
magnetic resonance tomography. Like many other prefilled containers, this
cartridge, including its tamperproof seal, also has to be brought into a
sterile condition by autoclave treatment. In order to ensure the
sterility of the assembly comprising the container and tamperproof seal,
liquid residues must not remain behind in the region of the tamperproof
seal during the drying operation. In order to prevent this, the parts
involved: the internal thread adapter, the rubber stopper and safety cap
are in contact predominantly via linear and/or spot-type contact. Large
capillary gaps in which residual moisture from the autoclave treatment
could be troublesomely retained are prevented.

[0007]The safety cap of the tamperproof seal has a break-off part which
surrounds the rear part of the rubber stopper without coming into contact
therewith in the radial direction, with respect to the centre line of the
tamperproof seal. However, said safety cap presses the rubber stopper in
a regaining manner against the outer cone of the lockable conical
adapter. By means of this configuration, it is possible to separate or
start to tear off the break-off part of the safety cap from the retaining
part thereof without the rubber stopper being pulled off the outer cone.

[0008]Further details of the invention emerge from the dependent claims
and the description below of a schematically illustrated embodiment.

[0019]FIG. 11: as FIG. 9, but pivoted through an angle of approx. 170
degrees.

[0020]In the exemplary embodiment, the present tamperproof seal serves to
seal a syringe barrel (10) in a sterile manner. To this end, the syringe
barrel (10) has a lockable conical connection in the form of an outer
cone (12) with an internal thread adapter (20) which can be latched into
position. The outer cone (12) is sealed by a rubber stopper (40), cf.
FIG. 1. A safety cap (60) is pulled over the internal thread adapter (20)
and the rubber stopper (40), cf. FIG. 2.

[0021]According to FIG. 5, the syringe barrel (10) has a barrel base (11)
which merges in the form of a funnel into an outer cone (12). The outer
cone (12), for example a Luer outer cone according to DIN 13090, Part 1,
has a central discharge bore (13). The discharge bore (13) has a cross
section of, for example, 5.6 mm2.

[0022]A truncated cone section (14) which has a cone angle of approx. 14
degrees and tapers in the direction of the outer cone (12) is located
below the outer cone (12). The length of the truncated cone section (14)
is approx. 1/3 of the length of the Luer outer cone.

[0023]An encircling annular channel (17), the channel base of which is in
the shape of a barrel casing, is located between the barrel base (11) and
the truncated cone section (14). The annular channel (17) is approx. 2 mm
wide. It serves to receive the internal thread adapter (20).

[0024]According to FIGS. 5 and 6, the internal thread adapter (20) is a
tubular body with a central stepped bore (22). The latter comprises a
threaded zone (23) and a plurality of bore sections (26, 28, 29). The
threaded zone (23) has an internal thread (24), for example a
double-threaded right-hand thread with a pitch of 5 mm, cf. DIN 13090,
Part 2. The threaded zone (23) is adjoined by a front bore section (26)
which has a diameter which is slightly smaller than the core diameter of
the internal thread (24).

[0025]The bore section (26) is followed by an adapter base (27) with a
central bore (28). The adapter base (27) is an inner flange which sits
with play in the annular channel (17) of the syringe barrel (10). Below
the adapter base (27) there is a rear bore section (29) which ends
towards the cylinder base (11), for example in a planar end surface (38).

[0026]The internal thread adapter (20) essentially has a cylindrical outer
wall (31) on which a plurality of longitudinal webs (32), for example 12
of the same, are arranged, cf. FIGS. 1 and 6. The rectilinear
longitudinal webs (32) are distributed equidistantly over the
circumference of the outer wall (31). They begin approx. 0.8 mm below the
upper end surface (21) with a 45° bevel and reach as far as the
lower end surface (38). The upper end surface (21) is rounded at its
outer edge, for example with a radius of 0.5 mm.

[0027]The individual longitudinal webs (32) have a semicircular cross
section, wherein the chord length thereof, positioned on the base of the
cross section, is approx. half the length of the arc length of the
respective gap (33) between two adjacent longitudinal webs (32).

[0028]An elastic rubber stopper (40) sits on the Luer outer cone (12), cf.
FIG. 5, said rubber stopper sealing the outer cone (12) in a tight and
sterile manner. The rubber stepper (40), which can also be manufactured
from a flexible plastic, is divided into two regions: a sealing region
(41) and a gripping region (51). The sealing region (41) comprises a
tubular section, the outer and inner walls of which each form at least
approximately a frustoconical surface. The inner wall (48) has a cone
angle with a cone angle tapering of 1:162/3, cf. Luer inner cone
according to DIN 13090, Part 1. The outer wall (46) has a cone angle of
approx. 3 degrees, with the imaginary tip of the cone, for example
according to FIG. 5, being located below the sealing region in the region
of the syringe barrel (10). The blind hole recess (42) belonging, to the
inner wall, cf. also FIG. 4, has a base (43) which is curved spherically
into the discharge bore (13). If appropriate, a for example conical pin
(44) is integrally formed on the base (43), said pin, bearing tightly in
some regions, projecting into the discharge bore (13), cf. the
dashed-line illustration in FIG. 5.

[0029]The blind hole recess (42) projects with approx. one fifth of its
length into the adjacent gripping region (51).

[0030]The gripping region (51) is substantially in the shape of a conical
bolt, on the outer wall (55) of which a multiplicity of gripping webs
(56), for example ten gripping webs, are integrally formed.

[0031]The outer wall (55) has a cone angle of approx. 5 degrees. The
gripping webs (56) have a constant cross section over their entire
length. The cross section is in the shape of a circular section, the
height of which, for example, is one third of the corresponding diameter
of the circle. The chord length, which is placed in the cross section
base of the gripping webs (56), is approx. three times the length of the
arc length of the respective gap between two adjacent gripping webs (56).

[0032]The gripping webs (56) are spherically rounded downwards and form an
axial collar (57). In the region of the cellar (57), the outside diameter
tapers to the outer wall (46) of the sealing region (41) by approx. 66%
of the maximum diameter of the gripping region (51). The gripping region
(51) has an upper end surface (52) which is labelled, for example and
inter alia according to FIG. 7. The end surface (52) is adjoined towards
the gripping webs (56) by a circular edge (53) which protrudes slightly
beyond the gripping webs (56).

[0033]After being placed onto the outer cone (12), the rubber stopper (40)
projects with the sealing region (41) fully into the threaded zone (23)
of the internal thread adapter (20), but without touching the base of the
threaded zone (23). In the process, the rubber stopper (40) is expanded
radially to such an extent that it partially touches individual turns of
the thread (24), cf. FIG. 8. The rubber stopper (40) bears with an
increased tension force in the front region of the outer cone end, since
the wall thickness of the rubber stopper is greater in the gripping
region (51) than in the sealing region (41).

[0034]The base (43) makes contact here in the axial direction with the
upper end surface (18) of the outer cone (12) in a, for example, planar
annular surface. In addition, the lower gripping web ends and, if
appropriate, also the collar (57) rest on the upper end surface (21) of
the internal thread adapter (20).

[0035]According to FIG. 2, the safety cap (60) is pulled over the fitted
combination, illustrated in FIG. 1, comprising the syringe barrel (10),
the internal thread adapter (20) and the rubber stopper (40). The
initially single-part safety cap (60) comprises a front retaining part
(61) and a rear break-off part (81). A break-off zone (97) is located
between the two parts (61) and (81).

[0036]The safety cap (60), cf. FIG. 6, is a cup-shaped body with a base
(91), in which the outer walls (63, 83) of the retaining part (61) and of
the break-off part (81), which outer walls are located one behind the
other, have a frustoconical basic shape. The cone angle of the basic
shape is, for example, one degree. The diameter of the outer walls (63,
83) increases at increasing distance from the base (91). On the basic
shape there are arranged, for example, twelve retaining webs (64, 84)
distributed over the circumference. All of the retaining webs (64, 84),
which are aligned, for example, in the longitudinal direction of the
safety cap (60), have trapezoidal cross sections. Said partially
different cross sections likewise taper towards the base (91).

[0037]The retaining part (61) has a frustoconical inner wall (68) the cone
angle of which is, for example, 1.2 degrees. The inside diameter of the
inner wall (68) increases here towards the break-off zone (97). In the
region of the lower end surface (78) of the retaining part (61), the
inner wall (68) has a partially encircling latching web (71), cf. also
FIGS. 10 and 11. The radially inwardly protruding latching web (71) has a
push-on flank (72) and a retaining flank (73). The push-on flank (72) has
a cone angle of 40 degrees. The imaginary tip of the cone lies in the
region of the break-off zone (97). The retaining flank (73) has a cone
angle of 120 degrees. The imaginary tip of said cone lies in the region
of the lower end surface (78).

[0038]In the lower region, the outer wall (63) of the retaining part (61)
has a step (65) of smaller wall thickness. In the longitudinal direction,
the step (65) is of a length which corresponds to approx. 33% of the
outside diameter there. Said outside diameter is approx. 6% smaller than
the diameter of the adjacent outer wall (63). By means of the reduction
in wall thickness, by approx. 46%, the retaining part (61) has a greater
degree of elasticity in the region of the latching web (71) than in the
rest of the retaining part (61). The step (65) which tapers towards the
lower end surface (73) has a cone angle of two degrees.

[0039]The retaining part (61) is of a length which is greater than the
average diameter of the retaining part (61) by the factor of approx.
1.13.

[0040]According to FIGS. 10 and 11, the inner wall (68) has two inner webs
(75, 86) which extend, for example, over the entire length of the safety
cap (60). Said inner webs are interrupted in the break-off zone (97) and
in the break-off part (81) by apertures (85) there, cf. FIG. 7. The inner
webs (75, 86) begin at the lower end surface (78). They are bevelled in a
roof-shaped manner there in the circumferential direction, cf. also FIG.
5. The inner webs (75, 86) each have a trapezoidal cross section, cf.
FIGS. 7 and 8. The web width is approximately half the width of the gap
(33) between the longitudinal webs (32) of the internal thread adapter
(20). The mutually opposite inner webs (75) are at a clear distance which
is always slightly larger than the outside diameter of the outer wall
(31) of the internal thread adapter (20).

[0041]The break-off part (81) has a frustoconical inner wall (88) which
has a cone angle of two degrees. The inside diameter of said inner wall
(88) tapers towards the base (91). In the outer wall (83), four at least
approximately rectangular apertures (85) are located between the
retaining webs (64), cf. FIGS. 2, 9 and 11. Said apertures are each
located in pairs next to each other while the pairs lie opposite each
other. The length of the apertures (85) is at least 60% of the length of
the break-off part (81). According to FIG. 2, the apertures (85) are
located by more than 50% in front of the rubber stopper (40). In the
exemplary embodiment, the apertures (85) together have an area of 52
mm2.

[0042]The base (91) likewise has two apertures (92). Each aperture is in
the shape of a part of a circular ring. They lie mirror-symmetrically
with respect to a plane positioned on the centre line (5). Their two
opening cross sections together have an area of 4.9 mm2.

[0043]A conical retaining pin (93) which is stiffened laterally by two
mutually opposite triangular supporting webs (95) is located between the
two apertures (92). The supposing webs (95) are supported between the
apertures (92) on the base (91). They do not reach as far as the lower
free end of the retaining pin (93). The retaining pin (93) is of a length
which corresponds, for example, to 64% of the average inside diameter of
the break-off part (81). Its free end surface (94), with which it rests,
when fitted, on the rubber stopper (40), has an area of at least 3.6
mm2.

[0044]The break-off part (81) is of a length which is larger than the
average diameter of the break-off part (81) by the factor of approx. 1.2.
Said length corresponds to the average thickness of an index finger.

[0045]At least three break-off webs (98) are located between the lower end
surface (96) of the break-off part (81) and the upper end surface (62) of
the retaining part (61). There are four of them in the present exemplary
embodiment. Each break-off web (98) is of the shape of an inclined
truncated pyramid, with the base surface of the truncated pyramid lying
on the lower end surface (96) of the break-off part (81), cf. FIGS. 5, 6,
2, 10 and 11. The surface of the roof of the truncated pyramid--i.e. the
transition surface to the retaining part (61)--is approx. one quarter of
the base surface of the truncated pyramid.

[0046]Next to in each case two mutually opposite break-off webs (98), cf.
FIG. 2, there are two supporting pins (99), which are integrally formed
on the break-off part (81), of the size of the break-off webs (98).
However, said supporting pins (99) do not touch the upper end surface
(62) of the retaining part (61). In the unloaded state, they are at a
distance of approx. 0.3 mm from the retaining part (61).

[0047]In order to produce the tamperproof seal, the internal thread
adapter (20) is first of all pushed onto the outer cone (12) of the
syringe barrel (10) in such a manner that its adapter base (27) latches
into the annular channel (17). The internal thread adapter (20) now sits
on the syringe barrel (10) in a manner such that it is freely rotatable
about the centre line (5). The rubber stopper (40) is pushed onto the
outer cone (12) until its blind hole base (43) rests on the end surface
(18) of the outer cone (12). In a final step, the safety cap (60) is
placed over the rubber stopper (40) and the internal thread adapter (20).
In the process, the two inner webs (75) of the safety cap (60) enter the
corresponding gaps (33) of the internal thread adapter (20). At the end
of the pulling-over movement, the retaining pin (93) is positioned
centrally on the rubber stopper (40) and, virtually at the same time, the
latching web (71) latches with its retaining flank (73) behind the lower
end side (78) of the internal thread adapter (20). The safety cap (60)
now sits captively and non-releasably on the syringe barrel (10). The
tamperproof seal is produced.

[0048]The break-off zone (97) is now located approx. 1 mm below the upper
end surface (21) of the internal thread adapter (20) and approx. 2.7 mm
below the upper end side (18) of the outer cone (12), cf. FIG. 5.

[0049]In order to open the syringe barrel (10), first of all the break-off
part (81) of the safety cap (60) has to be torn off for releasing
purposes. For this purpose, the break-off part (81) is held in the manner
of pincers between the thumb and the index finger and is loaded towards
the side, cf. FIG. 3. If the bending torque exceeds, for example, 25 Ncm,
the break-off webs (98) positioned in the pulling zone, to which the load
is applied start to tear off first. As soon as one break-off web (98) has
been torn off, the remaining webs also follow.

[0050]Since the rubber stopper (40) does not bear against the break-off
part (81), it is not released from the outer cone (12), not even if it is
temporarily deflected by an angle of up to 20 degrees during the breaking
off of the break-off part (81). The rubber stopper (40) is only pulled
off if the MRT cartridge is to be used. Until then, it remains sealed in
a sterile manner.

[0051]In order to pull off the rubber stopper (40), the latter can also be
pressed elastically to the side. In the process, it is supported on one
side by its collar (57) and/or the lower ends of the gripping webs (56)
on the upper end surface (21) of the internal thread adapter (20), which
makes it considerably easier to pull it off.

[0052]After the rubber stopper (40) has been pulled off, the assembly
comprising the retaining part (61) and the internal thread adapter (20)
can rotate freely on the syringe barrel (10), which makes it possible to
attach infusion instruments, for example, without rotating the syringe
barrel (10) itself.

[0053]The syringe barrel (10), the internal thread adapter (20) and the
safety cap (60) are manufactured for example from plastic. In this case,
each component (10, 20, 60) can be produced from a specific material.

[0054]In the above text, the terms "at the top" and "at the bottom" are
used repeatedly. They relate to the orientation of the component as
illustrated in each of FIGS. 1 to 6. What is at the top in said drawings
is also at the top of the component.